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>> good morning andwelcome to day two of the october 2016 acip meeting. thank you all forcoming back today. we have another very full day, and so we'll getstarted right away. we're going to start with abrief update on the zika virus, and we're very lucky to havems. stacey martin with us. we're borrowing her fromthe emergency response, so this session will be short,
and we will probablynot have a lot of time for questions, but let's go. >> thank you, good morning. thank you for the opportunityto provide this update. zika virus is an rna flavivirusrelated to dengue, yellow fever, japanese encephalitis,and west nile viruses. transmission to humansis primary by aedes species mosquitos. infection is typicallyasymptomatic
or causes mild dengue-likeillness. however, recently outbreakshave identified new modes of transmission andclinical manifestations. zika virus was first isolated from sentinel rhesus macaquemonkey in uganda in 1947. before 2007 only sporadic humandisease cases were reported from africa and southeast asia. in 2007, the first zika outbreakwas reported on the yap island in the federatedstates of micronesia.
in 2013 to '15, more than 30,000suspected cases were reported from french polynesia andother pacific islands. local transmission was firstidentified in the americas in may 2015 and subsequentlyspread across the region. as of october 13, there were47 countries and territories in the americas that hadconfirmed mosquito-borne transmission of zika virus. the map provides atimeline of the first reports of local transmission withbrazil confirming its first case
in early 2015 and the unitedstates confirming its first case this summer. the table reflects the number of locally transmitted zikavirus disease cases reported to paho by country in americas,now in excess of 660,000. approximately 60 percent ofthe total cases are reported from two countries,brazil and columbia. of note, most reportedcases are suspect cases, and only 23 percent arelaboratory confirmed.
most suspected and confirmedlocally transmitted cases reported to paho were reportedfrom south america followed by the caribbean andthen central america. zika virus disease was madeof notifiable condition in brazil in february 2016. for this reason temporal trends of cases are onlyavailable in 2016. there was an increasingtrend started in january that peaked in february.
since then there's been asteady decline of both confirmed and suspected reported cases. zika became a reportablecondition in columbia in october 2015. reported cases began to increasein august 2015, and continued until early february 2016. reported cases havedeclined since the peak. in mexico the first confirmedcase was reported in late 2015. in 2016, mexico reportedan increase in cases
that peaked in august. we are currently in epi week42 and given the expect lag in reporting it's too soon to say whether they haveexperienced a decline in cases. we've also recently learnedabout cases being identified in communities alongthe border with texas. in the united states, a total of 3892 travel-associatedcases have been reported to arbonet as of october 12.
ninety-eight percent of thesecases are travel-associated cases reported from the states. for locally acquired cases, a total of 25,999 cases havebeen reported, and 98 percent of these were reportedfrom puerto rico. in the states 128 locallyacquired cases have been reported to arbornet,all from florida. on the left the map showslaboratory-confirmed zika virus cases reported to arbornetby state or territory.
fourty-nine stateshave reported cases. the highest reporting statesare new york and florida, each reporting over 20percent of the cases followed by california and texas. all other stateshave reported less than five percentof the total cases. between january and october 14,2016, there have been a total of 3775 travel-associated casesand 137 locally acquired cases in the u.s. reportedto arbornet.
the epi curve suggests thenumber of reported cases peaked in july, but there isa lag in reporting. also, the u.s. reported itsfirst locally transmitted case in june from florida,and florida continues to report locallytransmitted cases. the majority of cases occur inadults with the highest number in 30 to 39-year-olds. travelers returning from thecaribbean represent the highest proportion of travel-associatedcases followed by travelers
from central america, southamerica, and north america. puerto rico reported itsfirst case at the end of 2015. the number of reported confirmedcases increased from january through august of 2016. following the peak, the numberof reported cases has declined. the puerto rico department of health has reportedover 28,000 cases. the cases are distributedthroughout the island. this is likely a significantunderestimate of the true number
of infections since theclinical presentation of zika virus infection istypically mild or asymptomatic. as previously mentioned,florida has reported over 100 locally acquiredzika virus infections. the first area to be identifiedwas the winwood neighborhood of miami dade countyfollowed by miami beach and then most recentlylittle river, also in miami dade county. to summarize, floridahas experienced sporadic,
locally acquired cases inmultiple counties in florida. many of these are believed tobe single transmission events without further spread. there are three areas that ihighlighted on the last slide that were found to havemulti-person transmission, which prompted cdc andflorida to recommend that pregnant women avoidtravel to these areas. in winwood, state andlocal officials appear to have successfullyended local transmission
after aerial spraying and othervector-control activities. as of october 17, floridahas reported 160 cases of locally transmittedinfections. concerns about low leveltransmission outside of the three designated areasprompted florida and cdc to recommend that pregnant women and their sex partners shouldconsider postponing nonessential travel to all partsof miami dade. as of yesterday, cdcrecommends laboratory testing
for all pregnant women whohad exposure to all areas of miami dade countyafter august 1. before i end, i wanted toprovide a very high level of review of zika virusvaccine development activities. a united states governmentinteragency working group that includes members fromasper, nih, sparta, fda, cdc, and rare was established to evaluate promisingvaccine candidates for safety, immunogenicity, and efficacyto ensure availability of one
or more candidate vaccinesin 2018 for emergency use in u.s. populations of highrisk of exposure of disease and to work with partnersto commercialize vaccines for broad distribution by 2020. currently, there aremany vaccine candidates in preclinical development,which you will hear about at a later date. there are expectedto four vaccines in phase one clinicaltrials by the end of 2016.
phase two studies arescheduled to being in 2017. thank you. >> thank you very muchfor that great update. are there one or two questions? [laughter] she's running back. >> sure. >> yes, ms. pellegrini. >> thank you forthat presentation. given that it appearsthat about 80 percent
of zika cases are asymptomatic,does cdc think it possible or likely, you said the numbers in puerto rico aredefinitely an underestimate, do we think that that 25,000plus could be 20 percent or possibly even less forpeople not seeking care at all of the actual number ofinfections in puerto rico? >> absolutely, yes, yes. i mean the only datathat we have that sort of gives us the ratio ofsymptomatic to asymptomatic is
from yap, but yes, it's believedto be about one to four, so that estimate is likelya dramatic underestimate of the true burden ofdisease on the island. any more questions? >> dr. hunter. >> once the epidemic curve hasrun its course in a population, what's the role of vaccinationin a country that is going to be endemic versus acountry that has, you know, different areas thatare going to be endemic
and others that aren't. >> that's a great question. i think you'll always havesusceptible populations that are in the new birthcohorts, but you're right, the use of vaccines maydifferent between a country that has had largeepidemics versus countries that have had endemic disease. >> one more, dr. sun [phonetic]. >> in puerto ricothere's endemic dengue,
in your epidemic curve for zika, can you superimpose the denguecases with the zika cases so that we can get asense of whether the fact that it's going away it's because the rainyseason is over, you know, there's less transmissionof all by mosquitos, or is it just a case of zikagoing away, you know, with the-- >> it's probably acombination of multiple factors. they had a large epidemic.
like we said, we think that estimate is asignificant underestimate of the true burden, so it has-- and you saw that most of theisland has been affected now, so i suspect the number ofsusceptibles has dropped. also, i don't want to make anycomments about the vector side because i'm not anarboviral expert, but it's likely multifactorial. [ background noise ]
>> one more. >> go ahead. >> dr. fryhofer. >> sandra fryhofer, americancollege of physicians. can you give us alittle guidance on what to tell patients whenthey're travelling to areas like french polynesia thatdon't have high levels of active infection right now but certainly havehad peaks in the past.
>> yes, the cdc is currentlyconsidering it's guidance for endemic areas. obviously pregnant women whoare traveling to any areas that may have transmission ofzika should take precautions. >> thank you so much for this. this was really a great update, and in february we will havea session on zika vaccine, so we will be introduced to sortof where we are with the state of the science in february.
thank you, again. now we'd like to do agencyupdates, and i'd like to start with dr. messonnier. >> good morning everybody,and thank you stacy. as you can imagine, thecdc remains very occupied with the zika response. dr. friedenalways characterizes as the most complicatedresponse cdc has ever managed. this is definitely partlybecause so many parts
of the agency are engagedbecause it is so multifactorial and also because thescience continues to evolve. back to paul's questionabout the use of vaccines. as always, we'll be comingto the acip for assistance in thinking about u.s.vaccination policy, and that is one ofthe reasons we wanted to make sure you got a littletouch of what's going on. onto other business,on september 29 cdc and nfid held a jointpress conference
to kick off the 2016-2017flu vaccination campaign. for the 2016-17 season, vaccinemanufacturers have estimated that up to 168 million doses of injectable fluvaccine will be available. more than 93 million doses of flu vaccine havealready been delivered. this season's vaccineshave been updated, and most of the researchsuggests that they will cover the strains
that are more commonduring 2016-2017. as of this week, overallinfluenza activity is low in the continentalunited states. if you saw the nisand the information around the flu vaccinekickoff, i'm sure you noted that adult flu vaccinecoverage this last year was low. we're obviously working to tryto understand that and to figure out what we can do to try andimprove flu coverage this year. the national immunizationconference was held
in september here inatlanta with thousands of immunization enthusiastsin attendance. it was actually thelargest number of attendees we've ever had fornic and certainly thank many of the individualsand groups in the room for their strong support. the next national adult and influenza immunizationsummit will be held in atlanta in may 2017.
as i'm sure you're aware,election season is upon us. cdc is working with thedepartment of health and human services and theoffice of management and budget to plan and prepare for anyadministrative changes to come, and the processeswill accelerate as we move followingthe election. finally, globally we'reconsistently reminded of the challenges ofbuilding global capacity for public health.
earlier this year,our colleagues in the cdc's global immunizationdivision released something called the strategic frameworkfor global immunization. it's a framework withoverarching goals to improve global healthimpact to increase the amount of people reached by strengthening country-ownedimmunization programs and cdc's foundationalgoal of providing evidence to affect policy andprogram implementation.
that framework wasavailable on the cdc website. international collaborationwill continue to be important as we look to enhance newtechnologies including for example learning about othercountries that are continuing to use the nasal fluvaccine this year. finally, there's also much wecan learn about vaccine policy from our international partners. we're really pleasedto have been able to welcome our colleaguesfrom china who are here
to discuss priority scientificactivities, and we're glad to have the opportunityto learn from each other. >> thank you. i'm just going to goright down the line here. so dr. birkhead,could you start for nvpo? >> thanks, good morning. i'll be reporting bothfor nvpo and nvac today. first for nvpo, as a companion to the national adultimmunization plan released last
february, nvpo plansto release a pathway to implementation report in thenear future to facilitate action on the goals of theoriginal plan. the pathway suggestseight priorities and potential activitiesto focus on down from the 78 strategiesin the original plan. they include addressingtechnical and legal and administrative and practicalbarriers to a great use of ehrs and immunization registries totrack adult immunization data,
evaluating the impact of currenthealthcare quality measures for adult vaccination,and the feasibility of developing compositemeasures, assessing the impact of financial barrierssuch as copays on adult vaccination uptake,identifying legal, practical and policy barriers impedingexpansion of adult immunization, encouraging all providers toimplement the nvac standards of adult immunization practice,engaging community leaders and promoting the importance ofadult vaccination to the public
and examining the totalcost of adult vaccination to adult vaccine providers ofproviding vaccination services such as vaccine ordering,handling, storage, administration, patient recalland reminders, counseling, etc. secondly, nvpo hasrecently awarded two contracts that may be of interest. the first contract addressesthe last point about the cost to providers of adultimmunizations by looking in detail at the businesscase for providers
of adult immunizations, takinginto account both the cost and the reimbursementby provider type and geographic region. the second contract is forthe development and testing of composite healthcarequality measure for maternal immunizations withmcqa, incorporating both tdap and influenza vaccinations. this was actually referencedyesterday in the discussion by carol hayes in the context
of the adult vaccine summitquality performance measure working group led byangela schen at nvpo. finally, for nvpo, nvpo andcdc are collaborating to put on a webinar entitledvaccines during pregnancy, a strong record of safety, to help providersaddress patient concerns around maternal immunization. the webinar will be on november9 from 12 to 1:30 eastern time and will cover the effectivenessof the flu and tdap vaccine
in pregnant women,their safety profile, and common mild adverse events, review the vaccine safetysurveillance efforts, and research activities specificto maternal immunizations and strategies and resourcesto address patient concerns around maternal immunizations. to view the webinar and register at the nvpo homepage at hhs.gov/nvpo. briefly, the nvac updates.
the last nvac meetingwas on september 20 and included presentations on cdc's 2016-2020 globalimmunization strategic framework, the mid-course review of the 2010 nationalvaccine plan was discussed. nvpo's pathway to implementationof adult immunization that i mentioned above, andfinally a review of the process of developing healthcarequality measures, and that discussion reallykicks off the process
to develop consolidate qualitymeasures, both for adult and maternal immunizations. at the meeting, nvacalso voted on and unanimously adopted amaternal immunization working group report calledovercoming barriers and identifying opportunities for developing maternalimmunizations, and that report isavailable on the nvpo website and will be published inpublic health reports.
the next nvac meetingis february 7 and 8 at the humphrey building andwill be available by webcast. >> thank you, dr. birkhead. now to the nih, dr. gorman. >> thank you, dr. bennett. this report will beappended to the minutes with all the weblinks, so when i go over things really quickly youcan get as much information as you want by surfing the web.
the revision of thecommon rule continues. the comment periodis now closed. approximately 1500 publiccomments were made during the comment period. each comment, some comments hadover 150 signatures on them. the agencies involved arenow reviewing these comments and making decisionson how to respond. the multiple agenciesinvolved are presenting driving towards consensus.
stay tuned. we've heard that there maybe an announcement soon. something that hasin fact occurred, nih is now requiringa single irb for all clinical trialsthat are multisites. the policy on the use ofa single institutional irb for multiple site studies waspublished on june 21, 2016, and this policy describesboth the rationale and the exemption criteriaduring the transition period.
in terms of personnel, there were two newinstitute directors. the national institute of mentalhealth has appointed dr. joshua gordon as its new director,and the national institute for child health and developmenthas dr. diana bianchi as their new director. in terms of niaid,niaid researchers in influenza havethe understanding of how influenza protectioncan facilitate the development
of a universal or broadlyprotective influenza vaccine. a nanoparticle vaccinebased on an hin1 stem rather than the ha headoffered protection against a lethal doseof an h5n1 challenge. this protection wasantibody based, but there was no developmentof neutralizing titers, which will present anissue as we go to try to license the new vaccines. in terms of personnel at niaid,
dr. steve holland was named thedirector of intramural research. for dmid, we continue to searchfor a new division director, but we understand thesearch is almost over. dr. fred cassels, thebranch chief for the enteric and hepatic diseasesbranch has retired from the governmentservice on september 30, and he is continuing his career with a new positionat taf. germain to some of ourdiscussions yesterday,
niaid is working on a new yellowfever vaccine which is not live, and a phase one studyis underway for safety and immunogenicity. and while this willnot answer the question about lyme disease vaccine, niaid is in early planningphases for a clinical trial to evaluate the effectivenessof prophylaxis of tick bites to prevent lyme disease. in terms of the zika virus,
niaid is actively pursuingmultiple vaccine candidates to prevent zika virusinfections. these strategies includea dna-based vaccine that uses a strategy similar to an investigationalflavivirus vaccine for west nile virus infection, and that entered early stagephase one testing in august of 2016, and the dosing of thoseindividuals is now complete. there is a lot of attenuatedinvestigational zika vaccine
building on a similarvaccine approach for a closely relateddengue virus. there is anotherinvestigational vaccine that is using a geneticallyengineered version, and it is attached to thevesicular stomatitis virus, and the plans are underwayto evaluate this candidate in tissue culture andthen in animal models. and the walter reedarmy institute of research has developed awhole particle inactivated zika
vaccine using a similarapproach that it's used for related japaneseencephalitis and dengue vaccines. also, the nih has launched alarge study of pregnant women in areas affectedby the zika virus. the nih and the brazilianministry of health has beguna multi-country study to evaluate the magnitudeof the health risks of zika in a natural history study.
the study is also opening inpuerto rico and will expand in several locations in brazil,columbia, and other areas. the zika in infants andpregnancy or the zip study plans to enroll 10,000 pregnantwomen ages 15 years and older and will follow themothers through pregnancy and the infants atthis point for one year for health-related outcomes. >> thank you verymuch, dr. gorman. dr. nair for hrsa.
>> good morning. i was going to providethe update on the national vaccineinjury compensation program. we had a very year processingclaims for fiscal year 2016. we received 1116 claims,and in the fiscal year, we awarded approximately$250,000 that were paid to petitioners and paid toattorneys for their fees for compensated and dismissedclaims as well as interim fees and costs and moreinformation and data
about our program canbe found on our website. we are in the process of updating the vaccineinjury table. comments on the notice for proposed rulemaking proposing changes to the vaccine injurytable have been reviewed, and a draft final ruleis being developed. it's currently going throughthe clearance process, and we hope to have thatfinalized and published
in the federal registry beforethe end of this calendar year. as of august 2016, our countermeasures injury compensation program has compensated 39claims totally $4.9 million, and that concludes my update. thanks. and for the fda, dr. sun. just a few highlightsof approvals since the last meetinghere in june. the fda has approved twoadditional seasonal influenza
quadrivalent vaccines,afluria and flublok. we also approved the use ofprevnar 13 for ages 18 to 49, and lastly you heardabout the approval of the hpv9 two-dose regimen. in addition, recognizingthe importance of the laiv for both seasonal andpandemic influenza, we have been working veryclosely with the manufacturer as well as representatives from the acip influenzaworkgroup and cdc.
further evaluation of root cause of this observationlower effectiveness and the influenza networkobservational studies. this includes work on manyfronts including manufacturing issues, further analysisof observational data, as well as virologicstudies, and we will continue to work closely toaddress these problems. >> thank you, dr. sun. for dod, dr. duzi.
>> thank you, and goodmorning dr. bennett. good morning acip. the department of defenseappreciates the valuable work of acip and the opportunityto participate in this work, which helps to protect ourcountry's service members, their families, and all of our 9.4 million dodbeneficiaries worldwide. i'd like to briefly highlighttwo current vaccine issues for the department of defense.
first, smallpox vaccine. the dod is working with themanufacturer of imvamune, the nonreplicatingsmallpox vaccine to fulfill the final phase threestudy requirement for licensure, and we expect completeenrollment by this december. imvamune is projected to meetthe u.s. government preparedness requirement for development of an attenuated smallpoxvaccine insufficient quantity to protect 66 millionpeople, comprising those
for whom replicatingthe smallpox vaccine is contraindicated andtheir household contacts. the second item that i'd like toaddress is yellow fever vaccine. yesterday, we heard anexcellent presentation on the current yellow fevervaccine supply challenges. the dod has worked veryhard to mitigate the effects of the yellow fevervaccine shortage through close collaboration withthe defense logistics agency, the military departments,
other federal partners includedhere today, and sanofi pasteur. as a result of this concertedeffort, the department of defense reduced utilizationof yellow fever vaccine by 80 percent but stillvaccinated all service members and beneficiariesdeploying to or traveling to a yellow fever endemic area. we look forward tothe availability of the expanded access i and d for stamaril discussedyesterday, and we will continue
to work with our partners onsolutions to this shortage. thank you very much. department of veteransaffairs, dr. pittman. >> hello. good morningeverybody. i have two brief updates. the va is nearing completionfor national release of its latest softwarepatches as part of the veterans immunizationenhancement 2.0 project. these patches improve support
for upcoming userfacing enhancements in its electronic medical record and the enterprise healthmanagement platform. they also providemultidivisional support for our larger integratedfacilities to track immunizationinventory more closely. va has partnered with walgreensfor the 2016-2017 flu season and will receivedata for veterans who obtain their immunizations
at walgreens duringthe flu season. this information willthen be available in the va's vista electronichealth record in any facility where that veteranis registered. indian health service,dr. groom. just two updates. as you may recall, indian healthservice had developed a policy to require influenza vaccine for our healthcarepersonnel last season,
but we had not successfullybargained it with the union so we were only ableto partially implement that in our facilities. even with just partialimplementation, we did see about a 10 percentincrease and had coverage of about 85 percent forour healthcare personnel. i'm very pleased to say thatwe have completed bargaining with two of the largestunions, and so 97 percent of our union employees arenow covered by this policy,
which we expect toimplement fully across the indianhealth service. so we're quite hopefulwe might actually achieve that healthy people20/20 goal this season, and we're really pleased tojoin the number of private and public institutions on the immunization actioncoalition's honor roll and have our federalmandate there along with our dod colleagues.
the other update is juston maternal immunization. we are partnering with hopkins to develop both aperformance measure for the indian healthservice to look at influenza and tdap vaccinationamong pregnant women but more importantly a reminder in our electronic healthrecord for our providers. >> great. thank you,and congratulations. that's great.
>> okay. we're going tomove on now to the child and adolescent immunizationschedule, and i'll ask dr.romero to kick us off. it's my pleasure tointroduce the work done by the child adolescentimmunization schedule workgroup. this slide showsthe acip members. on the workgroup, ms. pellegrini and dr. kempe, myself. our lead, who is dr.candice robinson, our liaison representatives andour consultants are shown here.
this next slide shows ouracip workgroup contributors and special thanksto all of them and in particularakiko wilson, who met and exceeded our requests forgraphic design of the new, which we will besubmitting to you, version of the immunizationschedule figure one. the reason this is beingpresented to you today, the acip members, is thatwe need to vote on this and approve it so that wecan move this for publication
in the mmwr january orfebruary of next year. we also need to get this toour members, the aap, the aafp, and acog for theirapproval prior to publication in the mmwr. so it's being broughtfor your approval. it's important to bear in mind that no new policyis being established in this presentation . this is simply thetranslation of the policies
that have already been madeat different workgroups and have been approved. the intent of the edits that aremade in the presentations are to improve the readability andthe utility of this document and schedule and to translate it so that these aciprecommendations can be in a language that is easyto interpret and easy to use by busy practitioners. the workgroup will bringspecific recommendations
with regard to specificfootnotes and in particular changes infigure one's configuration. there will also be theintroduction of a figure three, which we have calledthe high-risk figure for your approval. specific footnote changeswill be noted for hepatitis b, haemophilus influenzae typeb, pneumococcal influenza, meningococcal, and hpv vaccines. and i will now turn thisover to dr. candice robinson
for her discussion of each ofthese suggestions for your vote. so on the title page, thetitle page has been changed to update to the year 2017. in addition, thetitle has been changed to recommended immunization for children aged18 years or younger. this new title harmonizes with the new adultimmunization title, which will be presentedlater this morning.
in the 2016 versionof the schedule, the text beneath figure one waslargely a repeat of the text that already appeared on thetitle page of the schedule. in the proposed 2017 version,this text has been removed. other proposed figureone changes for 2017 include the following. the age 16 years has beenseparated from ages 17 and 18 years, and the 16year column has been shaded. the work group felt thischange would highlight the need
for meningococcal conjugatebooster dose at this age, and this may also providean opportunity for providers to catch up vaccinations if other adolescent vaccineshave not yet been administered or the series have notyet been completed. within the influenza row,laiv has been removed as a recommended vaccinegiven the acip recommendation to not use laiv during the2016-2017 influenza season. last year, a purple bar wasadded within the hpv row
at ages nine through ten yearsto represent the recommendation to begin the hpv series atage nine years in children with a history ofsexual assault or abuse. we received feedback fromproviders who indicated that this bar did notreflect the recommendation that hpv may be started atnine years of age for those without a history ofsexual assault or abuse. a blue bar has been added at agenine to ten years to indicate that vaccination maybegin at age nine even
if there is no history ofsexual abuse or assault. there are no proposed changes for figure two, thecatchup schedule. i will now introduce theproposed high-risk figure. the proposed high-risk figuredemonstrates that most children with medical conditions can andshould be vaccinated according to the routine immunizationschedule. it indicates when a medicalcondition is a precaution or contraindication tovaccine, and it also indicates
when additional doses of vaccines may be necessarysecondary to the child or adolescence medicalcondition. the proposed high-riskfigure is pictured here. the yellow color indicatesvaccination according to the routine scheduleis recommended. the purple color indicatesrecommended for persons with an additional risk factor for which the vaccinewould be indicated.
the black and yellow stippled or checkered pattern indicatesvaccination is recommended and additional dosesmay be necessary based on medical condition,see foot notes. the white color indicatesno recommendation. the red indicatesvaccination is contraindicated, and the orange color indicatesprecaution for vaccination. within the additionalinformation section of the footnotes,providers are referred
to the acip generalrecommendations on immunization and the relevantvaccine-specific acip statements for additional contraindicationand precaution information. additional changes within thefootnote include a bullet has been added on thenational vaccine injury compensation program. this addition wasmade to harmonize with the adult schedule, which already containedinformation regarding the
program and the vaccinescovered. the hepatitis b footnotewas updated to reflect the recommendationfor hepatitis b administration within 24 hours of birth,as voted upon yesterday. for infants born to hepatitisb surface antigen positive mothers, the post-vaccinationtesting window was updated to reflect the newrecommendation of testing at age nine through 12 months. within the haemophilusinfluenza type b footnotes,
hiberix was added tothe list of vaccines that may be administeredfor the primary hib series. additionally, comvax wasremoved from the list of available vaccines as thisvaccine is no longer produced, and all doses of thevaccine have now expired. language further down in thefootnote, which restricted use of hiberix to only thebooster dose has been removed. additionally withinthe hib section, in the catchup vaccinationportion, we clarified
that for unvaccinatedchildren age 15 through 59 monthsadminister only one dose. within the pneumococcalfootnotes, mention of pcv7 vaccine has beenremoved throughout the footnote. the last doses of pcv7vaccine expired in 2010. thus, children whoreceived pcv7 as part of a primary pneumococcalseries have since aged out of the routinepneumococcal recommendation. within the influenza footnotes,
information regardinglaiv has been removed, and the followingstatement has been added. for the 2016-17 season, use of live attenuatedinfluenza vaccine, laiv, is not recommended. the mmwr referencehas been updated to reflect the 2016-17 influenzarecommendations publication. additionally the finalbullet has been updated to notify providers to consultnext year's mmwr publication
for guidance. next, the meningococcalfootnotes. the clinical discretion sectionoutlines the meningococcal b category b recommendations. this section has been updatedto read, young adults age 16 through 23 years, preferredage range 16 through 18 years, may be vaccinatedwith a two-dose series of either bexsero at zeroand greater than or equal to one month, or trumenba,zero to six months vaccine
to provide short-termprotection against most strains of sero group b meningococcaldisease. additional guidance hasbeen added that states if the second dose of trumenbais given at an interval of less than six months, a thirddose should be given at least six monthsafter the first dose. within the meningococcalconjugate vaccine section, children with hivinfection have been added to the section regardingvaccination of persons
with high-risk conditions. the footnote regarding use ofmeningococcal b among persons with high-risk conditionswill remain unchanged. recommending a two-doseseries of bexsero at least one month apart or athree-dose series of trumenba with the second dose atleast one to two months after the first doseand the third dose the reference and websitefor the meningococcal and hiv infected persons, mmwr,
will be added once thecitation is available. within the tdap footnote,we have clarified the, we have added languageregarding vaccination among pregnant women. the footnote states, administerone dose of tdap vaccine to pregnant adolescentsduring each pregnancy, preferably early duringgestational weeks 27 through 36, regardless of the time sinceprior tdap or td vaccination. additionally, the catchupvaccination has been updated
to indicate that personswho receive a dose of tdap at age seven throughten years as part of a catchup series mayreceive a tdap at 11 through 12 years of age. finally, hpv footnotehas been rewritten to reflect the recommendationsapproved during yesterday's vote. routine vaccination now reads,administer a two-dose series of hpv vaccine on a scheduleof zero and six to 12 months
to all adolescents,age 11 or 12 years. the vaccination series canbe started at age nine years. administer hpv vaccines to alladolescents through 18 years who were not previouslyadequately vaccinated. the number of recommendeddoses is based on the age at administrationof the first dose. for persons initiatingvaccination before age 15, the recommended immunizationschedule is two dose of hpv vaccine at zeroand six through 12 months.
for persons initiatingvaccination at 15 years of age or older, the recommendedimmunization schedule is three dose of hpv vaccine at zero,one to two, and six months. a vaccine dose administered at a shorter intervalshould be readministered at the recommended interval. for special populations,children with a history of sexual abuse or assaultadminister hpv vaccine beginning at age nine years.
immunocompromised personsincluding those we hiv infection should receive a three-doseseries at zero, one to two, and six months regardless ofthe age at vaccine initiation. there is a note regardinghpv in pregnancy. hpv vaccine is not recommendedduring pregnancy although there is no evidence thatthe vaccine poses harm. if a woman is foundto be pregnant after initiatingthe vaccine series, no intervention is needed.
the remaining dosesshould be delayed until after the pregnancy. pregnancy testing is notneeded before hpv vaccination. a place has been added for thereference for the mmwr website and reference oncepublished and available. the questions beforethe acip for discussion and vote are as follows. does acip approve of the editsto the pre-existing portions of the child adolescentimmunization schedule.
does acip approve of theproposed high-risk figure for inclusion inthe 2017 schedule. we will have discussion,thank you. >> thank you verymuch, dr. robinson. we're going to have adiscussion now, but i'm going to beg you not to wordsmith. i know many of us areenglish majors in the room, and we may feel thatcompulsion; however, i think we should reallylimit our discussion
to conceptual issues, thingsthat you think are not clear on the schedule orthat pose a problem. if you have editsto the wording, i would ask that yousubmit them to dr. robinson, and they will be taken intoconsideration, but i really feel that we need to limitour discussion today to real conceptual issues. dr. szilagyi. >> yeah, hi.
as a primary care, first of all, thank you for a greatpresentation. as a primary care pediatrician, i think the high-risk figurecould be incredibly helpful. i think the next burden will beon our partner organizations, the aap and afp forhow to translate that into very practical methodssuch as prompts or alerts in the electronicmedical record or codes so that high-risk patientscan really be flagged,
how to really puthigh-risk patients into those appropriate buckets,but i think this will be very, very helpful forprimary care physicians. >> dr. moore. >> thank you, andthank you, candice. i think also that the high-riskfigure will be very helpful for those caring for children. i wanted to focus on the twovaccines that we are using now that may have a two-doseor a three-dose schedule,
which would be the fhbp,meningococcal b vaccine, as well as the hpvvaccine and just make sure that someone lookscarefully at the math on recommended intervals. if someone givesa dose too early, if they're doing atwo-dose schedule and they give the dose twoearly like less than six months, the recommendation forexample on the menb-fhbp was if it's zero andless than six months,
then repeat the dosesix months later, but that actually is muchlonger than the interval that you could use for anordinary three-dose schedule of that vaccine, which is zero,one to two, and six months. so we need to go backand look carefully at those minimum intervals. if you're intendinga two-dose schedule but you give it alittle early to make sure that you don't inadvertentlyinstruct the person based
on their intent torepeat the dose long after you would have ordinarilycompleted the routine three-dose schedule of that same vaccine. so i think the issue comes upboth for the menb-fhbp and also for the hpv and just tolook at the math and look at those minimum intervals whenyou're having to repeat doses. i know we have the convention of always repeating aninvalid dose, you know, at the recommended interval,
but in this case we haveshorter recommended intervals for the routine three-doseversion of that same schedule. so i just wanted to bring thatup, and you guys can figure out the math later, butit just struck me on both of those it might be an issue. >> yeah, thank you. and i will say the policy note for hpv does have some draftlanguage about what to do if you have a two-dose scheduleand a dose is administered early
or versus you had athree-dose schedule and a dose is administeredearly, and we can add portions of that policy note draft tomake it clear for providers what to do based on whatschedule they were attempting initially certainly. >> but we can go backto the subject matters for those two vaccines as well and make sure the policy notesmap is right and mentioned up at the top of the schedule.
>> great because the minimumschedule for an administration of three doses should notvary based on your intention to try a two-dose scheduleversus a three-dose schedule. there should just be oneminimum schedule regardless of what you intendfor those three doses. operationally, that'sreally important. i would kind of feel sillytelling someone they have to wait longer than they would if they were using aregular three-dose schedule.
other questions? dr. middleman. >> middleman, sahm. these are great, greatschedules, thank you so much. i just want to make sure, onyour slide it mentions the title and has the first paragraph. i don't know if you noticed, but it actually still uses theword children instead of person? and that's actuallya big conceptual--
all of the figures saysrecommended per person. >> yes. >> i think that'sjust a typo here, so i just wantedto confirm that. >> we can make thetitle persons aged or we can make it childrenand adolescents aged. i think we put children here because on the adult oneyou'll see it says adult there, so we can make itchildren and adolescents
or we can make itpersons, either or. >> yeah, conceptually, imean from a perspective, from a developmentalperspective in terms of what constitutes a child,an adolescent or an adult, they are developmental terms. >> yeah, absolutely. >> and it may it actuallybe more precise to use ages. that would be i think ourpreference in terms of, because we don't talkabout a toddler schedule.
it's a developmental stage. and the other thingi'd like to say is that sahm i think reallyappreciates the highlighting of placing in the schedule,four to six, 11 to 12, and 16 and where thereare sort of places where there's a new sortof place to have a vaccine, and so we reallyappreciate that highlighting. so thank you very much. >> dr. belongia.
that was very helpful, andthis is a really great figure for practitioners. i wonder if you can tell usa little bit about any plans of translating this for clinicaldecision support systems, which will be become increasingimportant going forward and sort of development of rules to sortof translate these categories into more sort of analytical,quantitative measures. >> absolutely. i think i will pass that overto dr. warden,
who will speak to that. >> yeah, i think the challenges of translating aciprecommendations into clinical decision supportis something we recognize well, and you know, we arecontinuing to think about how to incorporate thisinto working group work, but that's not something thatcan really be undertaken as part of the schedule process. it needs to be addressed withindividual recommendations.
and we are open to suggestionsfor how to proceed with that. this is sort of anongoing challenge that we're trying to take on. >> dr. kempe. >> just as a followup to that,i think i know of a number of different systems thathave already done this, so i think when you, ifyou're interested in engaging that process, i would begin withpeople that have already done it because i think it wouldbe much less duplicative.
>> thanks for that suggestion. >> yes, dr. lee. >> thank you, i actuallylove this figure, so i'm very excited for it. one thing that we talked about briefly yesterday wasstandardizing our terminology or perhaps providing examples ofwhat chronic liver disease was. i guess i would just ask ifwe can do a similar thing for all the categories.
some of these are very binary. some of them aremore challenging. level of immunocompromiseis sort of perhaps a difficultthing to assess, but it might be helpfuljust to give big buckets of guidance depending on for example levelof immunocompromise. >> so this is somethingthat we plan on addressing over the next year morecompletely throughout all
of our language andour recommendations, and so we can include that aspart of the process to make sure that these schedules are clear. is there a motionto approve the edits to the preexisting portions and to the proposedhigh-risk figure? dr. belongia. second. dr. kempe. any further discussion?
is there any public comment? seeing none, i thinkwe will start the vote. dr. hunter, would you liketo start and go to your left. >> hunter, yes. >> moore, yes. >> ezeanolue, yes. >> romero, yes. >> bennett, yes. >> atmar, yes.
>> stephens, yes. >> kemp, yes. >> szilagyi, yes. >> walter, yes. >> belongia, yes. >> riley, yes. >> lee, yes. >> pellegrini, yes. >> thank you very much.
i think we'll move onto the adult schedule. thank you, dr. robinson. and to introduce the adultschedule is dr. riley. so onto the big people. okay. first thing i'd like tothank cathy herriman [phonetic], who was our fearlessleader for a lot of years doing thisadult immunization group, and cathy had a remarkableability to cut through the forest offootnotes and succinctly get us
to where we needed to be. so thankfully she's goingto remain on the workgroup as a consultant, and thenwe're welcoming paul hunter, who is coming to us andbring his public health as well clinicalperspective to our workgroup. so, we are, as you know, going to discuss the adultimmunization schedule, which is updated yearly,just as the pediatric one is, and it's approved bya number of groups.
as you can see, the americancollege of physicians, the american academy of familyphysicians, the american college of obstetriciansand gynecologists and the american collegeof nurse midwives. and it is publishedin the mmwr as well as the annals ofinternal medicine. and so we are going to, thereare going to be several updates to the schedule andobviously these changes come from our acip recommendations,
and the good news isthere is a format change, so i'm sure everybody is onthe edge of their seats waiting to see what this newschedule will look like. and to end this, i'd liketo just thank the workgroup. as you can see, the acipmembers here, our consultants, our exam officio members,and then a long list of liaison representatives. and then finally a hugethanks to our cdc support, and i must thank ourfearless leader, dr. kim,
who will speak next, aswell as ledora woods, who keeps everything moving. >> thank you, dr. riley,for setting the stage for the 2017 adultimmunization schedule update. the 2017 adult immunizationschedule is now a six-panel document. it has a cover pageof introduction and general information, two figures withaccompanying footnotes,
and a table of contraindicationsand precautions. first, the updated cover page. so this is the cover page for the 2016 adultimmunization schedule. the title has been changed to recommend an immunizationschedule for adults aged 19 years orolder, united states, 2017, as dr. robinson mentioned forher immunization purposes. and it is now consistentwith the child
and adolescent schedule and thetext that was in the periphery of figures one and two in the 2016 has beenmoved to the cover page. and the revised coverpage introduces a list of acronyms used for manyvaccines routinely recommended for adults. when these changes areincorporated, the cover page for the proposed 2017 schedulecontains more information and looks like this.
so moving on to figure one,recommended immunization for adults by age group. this is what figureone currently looks like in the 2016 schedule. changes proposed for the 2017schedule include the following. revise the title andinstruction to the reader. combine age groups27 to 49 and 50 to 59 to create the newage group 27 to 59. the last of the adults bornbefore 1957 a phrase used
as evidence of immunity tommr will graduate into the 60 to 64 age bracket in 2017. time travels. use the acronymsintroduced in the cover page in the vaccine column. lump the live vaccines togetherto consolidate information and also to simplify graphics. use colored blocks instead ofcolored bars for indication. this is a big change,graphically speaking.
move the footnote on vaccineinjury compensation program to the cover page. remove the clause, zoster vaccine is recommendedregardless of past episode of zoster in the legend becausethe information is contained in the footnote forzoster vaccination. and, as mentioned earlier, movethe text to the cover page. so after incorporatingthese changes, this is what the proposedfigure one looks like.
moving on to figure two, recommended immunizationschedule for adults by medical conditionand other indications. this is figure twoin the 2016 schedule. first we'll mock itup with the changes that i already describedfor fig one. then were going to move thecolumn for msn to the right, next to the healthcare personnelto lump at-risk populations. then we update footnotesto link them
with the information specifiedby these medical conditions and other indications. and lastly, to reflect therecommendation made by acip in june to routinely vaccinateadults with hiv infection with sero group a, c, wny,meningococcal vaccine. change the color of theindication bar for this group to yellow, which stands forroutinely vaccine from purple, which means vaccinate ifanother risk factor is present. so when figure two in theprevious slide is updated,
this is what the newfigure two looks like. this is the proposed 2017 figuretwo recommended immunization schedule for adults by medicalcondition and other indications. now we move onto the table of contraindicationsand precautions. this is the 2016 table. while this table is availablethrough the acip website, it is a stand-alone document and not integratedinto the schedule.
it becomes a part ofthe schedule in 2017. changes in 2017 includethe following. one, include additionalgeneral information to explain the significanceof contraindications and precautions for vaccination. two, like figures oneand two, use acronyms for the vaccine column. a list of acronyms is locatedat the bottom of the new page. three, consolidatethe contraindications
and precautions that areapplicable to all vaccines and separately listadditional contraindications and precautions. and four, update precaution foriiv in egg allergy and state that laiv should not beused during the 2016-2017 influenza season. this is what the proposed 2017table of contraindications and precautions look like. as you can see, likethe other documents it's
in a landscape format. so next are the proposedfootnotes for the vaccines in figures one and two. the footnotes went througha substantial makeover. i'd like to take a moment nowto thank my cdc colleagues and acip workgroup membersfor making this happen. i won't explain to you allthe changes in the footnotes, and i suspect that youwouldn't want me to anyway, but i will describe foryou the main changes.
we removed the footnotesin the 2016 schedule for general informationand information on immunocompromisingconditions. that left footnotesassociated only with vaccines. for 2017, more detailed andvaccine-specific information on immunocompromisingconditions have been added to appropriate footnotesections. each footnote has been formatted into a general informationsection
that describes routinerecommendation and a special population sectionthat describes recommendations for groups identifiedin figure two. the language in thefootnotes has been combed over to read simplyand consistently. in the next few slides, i willpresent changes in the content of footnotes forseveral vaccines. the red text means addedor changed information. text that are crossedout means that they are
in the 2016 footnotesbut not in 2017. we'll start with the footnoteon influenza vaccination. the top line is ofcourse the recommendation that all personssix months of age or older should annuallyreceive the influenza vaccine. we've added that adults 65 or older may receive high-doseiiv or adjuvanted iiv. we remove the specificguidance for healthcare workers to receive the influenza vaccine
because they should begetting the vac anyway. we also needed to removethe option for laiv for healthcare workersand for everybody else for the 2016-2017 season. also, the use of influenzavaccine among adults with egg allergy hasbeen modified per acip recommendations made in june. and lastly, we added the clause, women who might become pregnantduring the upcoming influenza
season should receive iiv. the content of generalinformation and special populations for td, tdap vaccinationhas not changed. however, the acip votedyesterday to adopt a guidance for use of pertussisvaccination for pregnant women. the guidance reads currentlyavailable data suggests that vaccinating early in the 27 to 36 weeks will maximizepassive active body transfer
to the infant. to implement this guidance, wecan consider simply adding early to the already existingrecommendation for pregnant womenas you see here. in the footnote forvaricella vaccination, more detailed information onvaccinating healthcare workers, immunocompromised adults, and adults with hivinfection are added as these populations arespecifically identified
in figure two. similar to the footnoteon varicella vaccination, the footnote on zostervaccination now has more detailed vaccination on vaccinating immunocompromisedadults and adults with hiv infection. we removed the text thatexplained the difference in the age at which zostervaccination is recommended between acip and thevaccine package insert.
this decision was made becausethere are other vaccine uses that are off label,and we did not want to highlight oneparticular off-label use. we also felt that detailing thedifference could potentially cause confusion when we cannotfully describe the context. for hpv vaccination, we addedchanges that were approved by the acip yesterday. there is no change in routinehpv vaccination for adults. that is females through age26 and males through age 21
who haven't received hpv shouldreceive a three-dose series of hpv. we added the informationfor adequate vaccination with the two-dose hpv series. we also added information on vaccinating immunocompromisedadults, adults with hiv infection,and men who have sex with men. the acip voted yesterday torecommend a number of changes for hepatitis b vaccination.
one item from the acipvote was directly relevant for the adult immunizationschedule, and that is adding hepatitisc virus infection to the list of adults who are recommended toreceive hepatitis b vaccination. one other change item in the hepatitis bfootnote is the strike-out of immunocompromisingconditions as an indication in the red box are therecommendations made by the acip yesterdayon dosing of menb-fhbp.
the meningococcal vaccinationfootnote reflects this recommendation and therecommendation made during the june meeting that persons with hiv infectionsshould receive menacwy. in the 2017 schedule,adults with hiv infection, that's the second bullet onthis slide, are recommended to received two-dosemenacwy primary series and revaccinationevery five years. adults with hiv are notindicated to receive menb,
and adults at risk for serogroup b meningococcal disease are listed and recommended toreceive either a two-dose series of menb-4c or a three-doseseries of menb-fhbp. the new two-dose menb-fhbprecommendation does apply the young adults aged 16through 23 years of age who may be vaccinatedagainst sero group b meningococcal disease. when these changes areincorporated, the footnotes in the 2017 schedule wouldlook something like this.
it may be hard to tell, but thisis actually a big improvement as the font size isa tiny bit larger and there's more white space. and here's page twoof the footnotes. to wrap things up,i'd like to quickly go over what the next stepsare, give you an update on the adult immunizationevaluation initiative that i mentioned lastfall, and then open up the session for discussion.
after the discussion, andassuming that you vote to recommend thatwe move forward, we will revise the schedulebased on your feedback. along with the other decisionsmade during this meeting, the 2017 adult schedulewill be submitted to the cdc directorfor approval. we will then seekreview and approval from our partnerprofessional organization and submit the schedulefor cdc clearance.
when cleared, which willbe in early january, the 2017 adult immunizationschedule will be submitted to mmwr and the annals of internal medicinefor publication. with help from ourpartners, we will work to widely disseminatethe schedule to help to promote adult immunization. the 2017 adult immunizationschedule, as you saw, has gone througha lot of changes.
the graphics were evaluatedfor usability and simplicity. the text and footnotes andelsewhere were overhauled for readability,completeness, and consistency. but there's more work to doto improve it as a useful tool for healthcare providers. towards that end, cdc willkick off the adult immunization schedule evaluationproject in november. over the next year, we planto conduct in-depth interviews of healthcare providerswho use this schedule
to learn what their needsare, continue our efforts to improve the graphics andcontent of the schedule, and continue to work onimproving the implementation of acip recommendationsfor immunizing adults. thank you, and thatconcludes my updates on the 2017 adultimmunization schedule. >> thank you very much, dr. kim. dr. messonnier, would youwant to make a comment. >> yeah, i am, no, we typicallydid the vote on the schedule
on the first day,and then we had votes that impacted the schedule,which seemed out of order, so we purposely changed itthis meeting to the second day, and i want to thank david because he clearlyworked overnight to incorporate all the changesfrom yesterday to today, and i think he did a reallyjob of walking you through it. on the other hand, youhad in front of you copies with incredibly smallfont that none of us,
even if our vision wasperfect could read, and i know it's alot to incorporate. so if this approach didn't work,we'll keep trying to figure out how to give youbetter access to make sure that you have adequatetime to really think about the substantivechanges as opposed to the formatting changesbecause i saw multiple of you kind of trying to quicklyfigure out what was new and old. so if we don't haveit right this time,
i mean we'll keep working totry to make this manageable for you, at least one of you. >> similarly, i'dask you to, you know, keep your comment really, tryto focus on the content and not on the wording of things, andagain there will be ample time to get comments backto dr. kim and his team to have an impacton the wording. but now let me openit up for questions. dr. kempe.
>> not a question,but a comment. i think you've donean incredibly good job of simplifying it in termsof it's not scary to look at, and the footnotes althoughstill, you know, voluminous, are very well organized. i really think this isa great improvement. dr. lee. >> i will say, i likehaving it on the second day. in many ways i think that itreinforced that the intent
of the recommendationscame across in the wording of these recommendations. so i actually thought itwas great and appreciate that you probably pulledan all-nighter to do this. just a couple of questions that are actually outsidethese new recommendations. one is, well oneis semi-related, one being the zostervaccine, and i wonder if it should be distinguishedthat we're talking
about the live attenuatedjust because i wondered if as things change or evolveover time that it would need to be clarified eithernow or later. it's totally, i think whateverthe usual practice is fine. and the second was, andpart of it is thinking about the immunocompromisedpopulation, and i did not realize this aboutthe adult immunization schedules in the past, but the three doses of hib post stem cell transplantjust stands out to me in part
because we also, you know,do stem cell transplants in young kids, and so thatone recommendation seemed out of place in part because iwas trying to make it concordant with the persons 18 andyounger , and i was also trying to figure out why notthe other vaccines that we would also administer. so just wonder if perhaps that particular detailshould just be thought about a little bit.
>> just as a general reference,the adult immunization schedule as well as the child those two schedulesreflect decisions that have alreadybeen made by acip and approved for publication. and so the inclusionof select vaccines, and indeed adult immunizationcase, the inclusion of hib is because it is a part of notroutine as in everybody gets it, but there are indicationsfor that vaccine.
and because thereare exceptions, and frankly it's theseexceptions that drive the volume up on the list ofcomments in the footnotes, so where possible, we try tominimize these exceptions, working with value added made by these additionalcomments in the footnotes. but what we are trying todo is to be as comprehensive as we can based onthe recommendations that have alreadybeen made by acip.
>> and can i just add to that. i think that as part of whatwe're talking about in terms of making some of thesedefinitions consistent throughout the differentvaccines over the next year, i think we also intend to findsome of these inconsistencies in our recommendations where itmay be a needed inconsistency, but it may just be differentworkgroups proposing different things and to see if there's anyway we can harmonize in places where it seems reasonable.
>> sandra fryhofer, americancollege of physicians and american medicalassociation. dr. kim, thank you so much forall the hard work that went into this new schedule andthe streamlining changes. as far as the bars, theblocks instead of bars, it's very pretty, but onfigure two, it's not practical. if you look at figure two,when you're trying to pick one of those special conditionsand follow it down, you just, unless you're goingto, you know,
have a ruler that's see through, you can't tell whatgoes with what. so, you know, it's verypretty, but for figure two, i think it's a lotmore practical for the busy practicingclinician to be able to follow those headingsdown and figure out what immunizations thatparticular patient needs. the other thing,in footnote nine about the hepatitis bimmunization, i couldn't tell
from what were shownup on the screen. i hope that you actuallyinclude fatty liver disease, which was mentioned in thepolicy paper specifically because that is somethingthat we're seeing so much of in our practices. it might not be a conditionthat many clinicians realize as an indication forhepatitis b vaccination. >> dr. messoneia. >> can i ask, look at figuretwo, the high-risk figure
in the pediatric schedule,which has lines behind and would that solve the issue? i'm sorry, david. >> yeah. >> yes, it would. and i specificallycompared the two. >> that would be very helpful. dr. groom? >> thanks.
i really appreciate figuretwo and the idea of trying to put high risk, but i haveto say, when i looked at this, i went down the category andsaid, okay, high-risk, msm, purple, recommendedfor persons, okay. so msm should get pcv13and ppsv23 because the, just the way it was worded,if you aren't familiar that this is just for a certainmedical indication but not that medical indication, i'm pretty sure our cliniciansare going to look at this
and start telling me, wellwe have to pcv13 to all of our diabetic patients. and i don't know if thatfootnote could be changed to say maybe recommendedfor patients with the appropriate medical,but this is the high-risk table, and when you see that condition,i'm just afraid you're going to assume that ifit's purple it means that high-risk person shouldget it because they're in that special risk group.
>> dr. thompson. >> yeah, i also applaudthe efforts to really develop these tables. it's a big step forward,i think. i did note that it wasinteresting that the table for the younger individuals,those under 18, don't include an msm column,and of course, you know, there are some differencesbetween these two tables also in the pregnancy columns,which appear in both.
just to note that tdap,which would be recommended for each pregnancy, soit's probably unusual that there are many individualswho have two children under the age or, or twopregnancies under the age of 18, but what is the recommendationin that case? how is the clinicianreconciling these two things, and i just think theadolescents are kind of falling through the cracksa little bit still. and so kind of reconciling thesetwo things might be useful.
also, it wasn't clear to mewhy the vaccines were listed in the order thatthey were listed. it seemed to me that theycould be listed alphabetically or at least in the sameorder on both charts, so anybody who's looking at, youknow, how do we handle adults and how do we handlechildren might be able to look at it that, but that's just because i'm lookingat it simplistically. maybe there is a logic.
it just seemed to me that consistency would be yourfriend here, so thank you. >> yeah, and i can speak to theexclusion of msm on the child and adolescent one, andthat's because for vaccines for which adults vaccinationrecommendations differ by msm status, they don'tdiffer for children. so for instance, in hpv forthe adult males you have those who are 22 to 26 who get it ifthey're msm, but for children, all adolescents through 18,which is the upper limit
of that figure, receivethe vaccine, so that's why that was left off there. >> and regarding the orderof vaccines presented for figures one and two, theywere actually done with graphics in mind because asi understand it in the years past an effort wasmade to go by alphabetic order, and simply did not work becauseof the complexity that it seemed to impose for theeyes to follow. and other attempts were made
with different colors,different shades. let's see, the hashingof the bars and other attempts were made,but i think through trial and error, granted they wereskilled trial and skilled error, the current listing has beenmade, and as i work with it more and more, i thinkit makes more sense. but if there are recommendationsto improve on that, certainly we'll be open. >> dr. romero.
>> the order, thecomment about the order for the childhood adolescentimmunization schedule, that in reality is an attempt to reflect how these vaccinesare used and the timing in which they are used. so we did discuss puttingthem in alphabetical order, but it makes more sense,at least to the group, it made more sense toleave them in the order in which they're beingintroduced to the children.
>> i'm wondering if one of theconcerns might be addressed by using the same wordingfor the purple color that's on the childhood one, whichbasically says you have to have an additionalrisk factor for which the vaccinewould be recommended. i'm not sure, i haven'tgone through this in detail. but i'm wondering ifthat wording would help with the issue youraised in terms of, or using the hatch marks,and i'm not sure, but that,
you know, those twowordings were created because of the concern youraised, which is you go down and you can't tellif that's indicated or whether there areadditional doses needed. so i would just look at thosetwo options for the graphics. >> dr. messonnier. i appreciate all the comments. i think one of the issues iswe don't really know experience for adult providers howthey use the schedule.
it's clearer to usfor pediatricians that they're using itroutinely, that it's part of their normal practice,and i think we have vetted that schedule a lot andreally understand it. this issue of the adult scheduleand the extensive footnotes, you know, were not, and soas david was explaining, this is really our firststep towards moving the adult schedule. the questions that youall are asking are some
of the same questions that we'reasking, and it's what we hope to get at through sort oftesting of the schedule with adults and alsoasking how many of them actuallyuse this schedule versus use clinicalsupport tools versus a lot of people use online,you know, aids, as opposed to actually a hard, flat copy of theschedule up on the wall. and so, you know, you're goingto be hearing more about this
for the next year, but whatyou're saying are things we know. we don't necessarily wantto make dramatic changes now until we do the restof the evaluation that we really should come to a better scheduleat the end of it. i'd like to go tothe microphone. you've been waitingfor a long time. >> actually i was comfy.
wayne hashi [phonetic]from protein sciences. i just had two comments as far as the footnote oneunder influenza. the first is under pregnantwomen and women who are planning to become pregnant or couldbecome pregnant during the upcoming flu season. it says that theyshould receive iiv. i would suggest that youalso add riv to that. riv does have a class bcategory for pregnancy
and also doesn't have a lot ofthe extra stuff in the vaccine that many pregnant women avoidinfluenza vaccines because of. the other is for adults aged 65 or greater may receivehigh-dose iiv or adjuvanted iiv, suggest a preferentialstatement. if you do want to includeall of the vaccines that have increasedeffectiveness, there will be some data thatshows increased effectiveness in those 65 and older,
then again riv shouldbe added to that group. we submitted data toboth the work group and to this body showing that flublok had increasedeffectiveness in the over 50 populationto include the over 65 populationduring flu season and in this case markedby vaccine mismatch. so the worst of all conditions, flublok still providedprotection
for the over 65 group. i think the bottom line is beingsure that the recommendations on the schedule matchthe recommendations of the influenzarecommendations. additional comments, dr. hunter. >> this is paul hunter. i just wanted toaddress the issue of how the schedules areused in clinical practice from my impressionboth as a clinician
and as a public healthpractitioner. i think we're not talkingabout as much the audience that really does vaccination,which is medical assistants and nurses and thatwe really need to include their impressions of how the schedulesare being used. and also that my impressionof how they are being used is within the context offorecasts that get printed out from registries
or the electronic health recordis what's maybe more specific for that particular patient,but they look at the schedule to double check it and saydoes that really make sense. and now can i go and look atmy standing order hopefully and give the shotto the patient. so that's my impression ofhow the schedules fit in. >> and that's a perfectsegue to ms. hayes. >> carol hayes with the americancollege of nurse midwives. i just want to registermy objection
to using the word lifestyle. i don't think it'sclinically appropriate, and i would like to sort ofmirror what dr. kemp said, that's using thelanguage for purple that's on the persons under18 schedule. >> doctor, do you want tocomment dr. [inaudible]. did you want to respondto that or no? >> that is actually, i'mhesitant to comment on that because that's not a decisionthat's made by me or our,
it is a reflection of thecontent of what was in the, the content of previouspublications on acip policy. so to address that,it is something that acip could address andalso by the community that deals with these issues in general. i do want to echothe encouragement that if it's feasible at allto use exactly the same wording on the purple bar for boththe adults and the children, that would clean up thatquestion about lifestyle,
but also it just helps. if you're using the same color,then people who treat children and adults will anticipate that when they see the samecolor it means exactly the same thing. and my even havingslightly different words, that can through them off and like do they reallymean the same thing. so i just encourage thatsort of definitions of terms,
so i think that wouldaddress that. >> dr. messoneia, do you want-- >> yeah, in an effort tonot get you guys caught up in wordsmith thing, i mean wewill take a look at this and see if there's a way to makethe language more harmonious with the childhood schedule and also avoid whateverpitfalls we can. so, yes, we'll takeit under advisement. dr. fryhofer?
this is just a responseas to how internists and other cliniciansthat take care of adult patientsview the schedule. i think internists, and ican speak as an internist, are having to grapple withthe increased complexity of adult immunization, andi think we have to learn from our pediatric colleaguesand become more disciplined in looking at this schedule. it is so totally differentthan maybe what we were trained
where many of us received intraining during residency. but it is a fact of life,and it's a wonderful fact that we now have allthese wonderful ways to keep people healthy. so the american college of physicians has many effortsunderway and initiatives to help increaseinternist knowledge and use of the schedule, and itis a very valuable tool. so dr. kemp, the work thatyou and your colleagues
and the members ofthe [inaudible] done in making this a go tosource is greatly appreciated and so will the change onfigure two from back to bars. dr. moore. >> yes, thanks. i did have a followup, andi'm really not trying to get into wordsmithing, but i thinkgoing back to my three-dose versus two-dose comment, a niceway to deal with this based on some feedback i hadfrom cdsi folks who work
in registry programming,which is something we have to think about, is simply thatfor vaccines that may be given on a two-dose orthree-dose schedule, if the minimum interval for atwo-dose schedule is not met, please use the three-doseschedule or complete using the three-doseschedule, and then you don't get into all of the convolutedlanguage about invalid doses. you simply say if you don't meetthe two-dose minimum interval, complete using the three-doseschedule, and then you kind
of eliminate all that. >> thank you for that comment. i think the group willtake those comments about the two-doseversus three-dose back to the drawing board andwork on that wording. dr. savoy [phonetic]. >> dr. savoy, americanacademy of family physicians. two things. so, one, if i'm understandingcorrectly, the schedules
that we're looking at hereare just recommendations that you've alreadymade somewhere else, and so we can't just change thelanguage for what you're going to put here because wedon't like what it says. it means that we wouldhave to go back and find where the original sourcerecommendation came from and then bring that back tothe committee and talk about it and then update that, andonce you vote on that, it could be included on this.
so this is just a summary ofwhat has already been decided. so somewhere, somewhereit says lifestyle, and so that's the reason whylifestyle would appear there. so it can't just bethat we edit it here. i think you have to go back andfind the source recommendation. and the second thing is abouthow primary care providers in general use the schedules. what we find forfamily physicians that luckily we did gettrained to use both schedules
in training because we have totake care of the whole spectrum, and the pregnant women, so wedon't really get a pass on any of the groups of people. but what i'm finding isthat an increasing number of people are using electronicways of managing the schedule. so although everybody's officepretty much has this schedule stuck up on a wall somewhere andlaminated so that we don't get in trouble for having stuff onthe wall that's not laminated. the vast majority of peopleare getting their information
from some version ofan electronic thing. so either somebody takes thisschedule and translate it into an app that people areusing, so there's a variety of different appsthat i've heard of, or they're using it directly outof their emr or their registry for their state ispulling that information and sending themthe information. so even though we spend alot of time sort of thinking about how pretty it looks or howto make it work, i'll be honest
with you, i don't thinkthe vast majority of people for either the peds schedule orthe adult schedule are spending as much time lookingdirectly at this schedule as they are the contentof what's behind it. and so i would be, iwould be more interested in you all being really crystalclear about the definitions of what you want andthe start and end point so that the registriesare as accurate as possible thenworrying as much
about the lines,from my perspective. dr. pittman. >> hi, this is cathypittman from the department of veterans affairs,and i'll just say that we eagerly awaitthe release of the adult schedule everyyear, and we ask dr. kroger to come on and have a webinarfor our people in the field to talk about the changes,and it's very received. so thank you.
and we do use these totranslate into electronic ways because it is getting moreand more complex, and, well, my aging brain can'tkeep it all up here. >> thank you, dr. belongia. >> i just wanted to followup. i was thinking about the commentregarding the flu vaccine, and i think it's a valid point that since acip doesn't makeany preferential recommendation for any particular product,
either it should say use anylicensed influenza vaccine or it should list all of them. ms. stinchfield. >> patsy stinchfieldfrom netmap. i just wanted to underscorethe earlier comment about the end users,the mas and the rns, and our schedule work group, thechildhood schedule, really takes that into consideration andtalks about it quite a bit. and the cdc did send out ateam to children's minnesota,
our clinics, and did focusgroups and actually talked to most of our mas and havedone it across the country, so it's a really importantpoint to keep focused on. i appreciate that. dr. fryhofer. >> thank you so much. and one final comment. i have to add to thisdiscussion the importance of eventually getting anational immunization registry.
because the adult schedulehas become so complicated, it's sometimes very difficultfor a practicing clinician to know which vaccines togive, because you don't know which vaccines thepatients have received. right now i've heard somuch talk about emrs. well if someone putsa vaccine in the emr, some of the emrs will goto the state registry, but we don't alwayslive in one state, and right now the registrydoesn't speed back to the emr.
so i have patients that aregetting over vaccinated, that are gettingunder vaccinated because we don't have--you know, with children, they can't go to school unlessthey have these immunizations. when kids go to collegethere's usually a checkup on immunizations. but we don't have a similarcheckup when patients, you know, have a new job unlessyou're in healthcare, so national immunizationregistry will be really helpful
in improving, youknow, the interface between these registries and emrs would bevery helpful as well. >> i very much support theprospect of a national registry. however, we recently did anational survey of internists and family medicine andpeds across the country, and the fact is, avery small minority of internal medicine physiciansunfortunately are using their state registry.
so a national registryisn't going to work unless there's much moreconsistent use of registries by adult providers, andi think that's really where we need to go first. okay. i think we've talkedthis through a great deal. i'd like to ask for a motion to approve the adultimmunization schedule. dr. riley. is there a second?
>> second. any further discussionor public comment? anybody. i'm notseeing any hands. am i missing anyone? great. okay, thenlet's go to a vote. dr. lee, would you start usout and go to your right. >> belanga, yes. >> kempe, yes. >> atmore, yes.
>> that's great. thank you so much. we've approved the adultimmunization schedule. thank you to dr. kim. and thank you forrestraining your comments to real content comments. this really went very well,and i think there was a lot of very useful feedback fromthe committee and others. and remember, if you havefurther comments or additions
or wording changes, please feelfree to get them to dr. kim so that they can be incorporatedin the adult schedule. so we are way ahead of schedulebecause everybody's been so great, and so i thinkwe'll take a break now.
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